British Journal of Renal Medicine - 2003

Comment: The EU Clinical Trials DirectiveJohn Bradleypp 4-4Renal medicine in the UK has often been slow to make progress with clinical trials. David Jayne outlines the advances made in recent years. Continued progress will undoubtedly be influenced by the implementation next year of the European Union Clinical Trials Directive. The directive was published in May 2001. It provides for protection of human subjects, including minors and incapacitated adults, but will increase the complexity and cost of clinical trials.

Nutrition and renal diseaseJohn C Hartypp 6-8For many in the nephrology community, the concept of nutrition is equated with redundant low-protein diets and the dubious prescription of dietary supplements. There have, however, been substantial developments in our understanding of nutrition and its impact on renal disease. In this overview I will highlight six areas in which recent advances have emphasised the relevance of nutrition to the renal patient.

Educational provision for children with chronic renal failure – ‘could do better’Roger Stephenson and Alan R Watsonpp 9-11Educational progress is one of the key considerations in the management of children with chronic renal failure. One of the reasons that renal transplantation is favoured so strongly in children is that restoration of good health and freedom from dialysis will allow them to attend school on a regular basis, improving their educational attainment and enabling them to develop peer and social relationships.

What I tell my patients about reducing infection risks during haemodialysisIan Bowler, Paul Altman, Rainer Buhler, Mary Jeffrey, Alison Cornall, Jenny Hayes, Catrena Lewis, Allie Thornley and Leanne Collinspp 13-16There are some infection risks associated with haemodialysis treatment. This article will explain some of these risks and the strategies that are commonly used to reduce them. There are a variety of ‘bugs’ or ‘germs’ that can cause infections. They are too small to see and so are often referred to as micro-organisms. The two different groups of micro-organisms that may cause infections are bacteria and viruses.

Reactions to therapeutic proteins and their preventionLorna Thomson, Julia Marley and Neil Turnerpp 17-19In the last three years in Europe, there has been an increase in reported cases of pure red cell aplasia (PRCA), a rare adverse event caused by autoimmunity to erythropoietin in patients treated with recombinant human erythropoietin (rHuEPO). Antibodies formed to rHuEPO cross-reacted with the low levels of EPO still produced by patients, so that the patients had essentially no EPO at all. In these circumstances, the bone marrow makes almost no red cells, resulting in PRCA. Because the side-effect is rare, the proportion of patients affected has been very small. Nevertheless, the phenomenon has caused understandable concern, and also interest in how such complications come about.

Home or hospital – what is the place of home haemodialysis?Ken Collinspp 20-22Provision of care in the UK for patients with endstage renal failure (ESRF) has expanded considerably over the past 30 years as the number of hospital and satellite-unit haemodialysis facilities have increased. This year, the National Institute for Clinical Excellence undertook a systematic review of the effectiveness and cost-effectiveness of home versus hospital or satellite-unit haemodialysis for ESRF patients.

Clinical trials in nephrologyDavid Jaynepp 23-27There has recently been an increase in investigator- initiated therapeutic trials in nephrology in the UK. These are multicentre trials, which serve both to optimise current practice and to assess new therapies. They have attracted wide support from practising nephrologists and have demonstrated that large-scale trials can be successful in uncommon renal disorders. This article will outline the necessary scientific and regulatory hurdles to be overcome and will review several ongoing trials.

The British Journal of Renal Medicine was previously supported by Baxter Healthcare from 2011 to 2013, by Sandoz in 2011, by Shire Pharmaceuticals from 2006 to 2011, by Ortho Biotech and Shire Pharmaceuticals in 2005, by Ortho Biotech from 2000 to 2005 and by Janssen Cilag from 1996 to 2000.

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